Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

Gender disparity between authors in leading medical journals during the COVID-19 pandemic: a cross-sectional review.

OBJECTIVES: Evaluate gender differences in authorship of COVID-19 articles in high-impact medical journals compared with other topics. DESIGN: Cross-sectional review. DATA SOURCES: Medline database. ELIGIBILITY CRITERIA: Articles published from 1 January to 31 December 2020 in the seven leading general medical journals by impact factor. Article types included primary research, reviews, editorials and commentaries. DATA EXTRACTION: Key data elements were whether the study topic was related to COVID-19 and names of the principal and the senior authors. A hierarchical approach was used to determine the likely gender of authors. Logistic regression assessed the association of study characteristics, including COVID-19 status, with authors' likely gender; this was quantified using adjusted ORs (aORs). RESULTS: We included 2252 articles, of which 748 (33.2%) were COVID-19-related and 1504 (66.8%) covered other topics. A likely gender was determined for 2138 (94.9%) principal authors and 1890 (83.9%) senior authors. Men were significantly more likely to be both principal (1364 men; 63.8%) and senior (1332 men; 70.5%) authors. COVID-19-related articles were not associated with the odds of men being principal (aOR 0.99; 95% CI 0.81 to 1.21; p=0.89) or senior authors (aOR 0.96; 95% CI 0.78 to 1.19; p=0.71) relative to other topics. Articles with men as senior authors were more likely to have men as principal authors (aOR 1.49; 95% CI 1.21 to 1.83; p<0.001). Men were more likely to author articles reporting original research and those with corresponding authors based outside the USA and Europe. CONCLUSIONS: Women were substantially under-represented as authors among articles in leading medical journals; this was not significantly different for COVID-19-related articles. Study limitations include potential for misclassification bias due to the name-based analysis. Results suggest that barriers to women's authorship in high-impact journals during COVID-19 are not significantly larger than barriers that preceded the pandemic and that are likely to continue beyond it. PROSPERO REGISTRATION NUMBER: CRD42020186702.